87784 Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Notices 

21 CFR part or guidance Topic OMB control 

No. 

807, subpart E ............................................................................ Premarket notification ................................................................ 0910–0120 

814, subparts A through E .......................................................... Premarket approval .................................................................... 0910–0231 

814, subpart H ............................................................................ Humanitarian Use Devices; Humanitarian Device Exemption .. 0910–0332 

812 .............................................................................................. Investigational Device Exemption .............................................. 0910–0078 

860, subpart D ............................................................................ De Novo classification process .................................................. 0910–0844 

‘‘Requests for Feedback and Meetings for Medical Device 

Submissions: The Q-Submission Program’’.

Q-Submissions and Early Payor Feedback Request Programs 

for Medical Devices.

0910–0756 

822 .............................................................................................. Postmarket Surveillance of Medical Devices ............................ 0910–0449 

50, 56 .......................................................................................... Protection of Human Subjects and Institutional Review Boards 0910–0130 

601 .............................................................................................. Biologics License Application .................................................... 0910–0338 

803 .............................................................................................. Medical Device Reporting .......................................................... 0910–0437 

‘‘Administrative Procedures for CLIA Categorization’’ and 

‘‘Recommendations: Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’.

CLIA Administrative Procedures; CLIA Waivers ....................... 0910–0607 

800, 801, 809, and 830 .............................................................. Medical Device Labeling Requirements; Unique Device Identification.0910–0485 

860 .............................................................................................. Reclassification Petition for Medical Devices ............................ 0910–0138 

‘‘Emergency Use Authorization of Medical Products and Related Authorities’’.EUA ............................................................................................ 0910–0595 

Dated: December 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27852 Filed 12–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2058] 

James Funaro: Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) debarring 

James Funaro for a period of 5 years 

from importing or offering for import 

any drug into the United States. FDA 

bases this order on a finding that Mr. 

Funaro was convicted of one felony 

count under Federal law for conspiracy 

to launder money. The factual basis 

supporting Mr. Funaro’s conviction, as 

described below, is conduct relating to 

the importation into the United States of 

a drug or controlled substance. Mr. 

Funaro was given notice of the proposed 

debarment and was given an 

opportunity to request a hearing to show 

why he should not be debarred. As of 

October 11, 2023 (30 days after receipt 

of the notice), Mr. Funaro had not 

responded. Mr. Funaro’s failure to 

respond and request a hearing 

constitutes a waiver of his right to a 

hearing concerning this matter. 

DATES: This order is applicable 

December 19, 2023. 

ADDRESSES: Any application by Mr. 

Funaro for termination of debarment 

under section 306(d)(1) of the FD&C Act 

(21 U.S.C. 335a(d)(1)) may be submitted 

as follows: 

Electronic Submissions 

D Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

An application submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

application will be made public, you are 

solely responsible for ensuring that your 

application does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

application, that information will be 

posted on https://www.regulations.gov. 

D If you want to submit an application 

with confidential information that you 

do not wish to be made available to the 

public, submit the application as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

D Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

D For a written/paper application 

submitted to the Dockets Management 

Staff, FDA will post your application, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All applications must 

include the Docket No. FDA–2023–N– 

2058. Received applications will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

D Confidential Submissions—To 

submit an application with confidential 

information that you do not wish to be 

made publicly available, submit your 

application only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of your application. 

The second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. Any information marked as 

‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https:/ 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Notices 87785 

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket, go to 

https://www.regulations.gov and insert 

the docket number, found in brackets in 

the heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500, 

between 9 a.m. and 4 p.m., Monday 

through Friday. Publicly available 

submissions may be seen in the docket. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Espinosa, Division of Compliance 

and Enforcement, Office of Policy, 

Compliance, and Enforcement, Office of 

Regulatory Affairs, Food and Drug 

Administration, at 240–402–8743, or 

debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(1)(D) of the FD&C Act 

permits debarment of an individual 

from importing or offering for import 

any drug into the United States if FDA 

finds, as required by section 306(b)(3)(C) 

of the FD&C Act, that the individual has 

been convicted of a felony for conduct 

relating to the importation into the 

United States of any drug or controlled 

substance. 

On February 27, 2023, Mr. Funaro 

was convicted, as defined in section 

306(l)(1) of the FD&C Act, in the U.S. 

District Court for the Western District of 

Michigan, when the court entered 

judgment against him for the offense 

conspiracy to launder money in 

violation of 18 U.S.C. 1956(h), 

1956(a)(1)(A)(i), and 1956(a)(1)(B)(i). 

FDA’s finding that debarment is 

appropriate is based on the felony 

conviction referenced herein. 

The factual basis for this conviction is 

as follows: as contained in the 

indictment and plea agreement in Mr. 

Funaro’s case, filed on March 1, 2022, 

and July 29, 2022, respectively, 

beginning in or about 2018 and 

continuing until in or about October 

2021 several individuals ran a website, 

www.ExpressPCT.com, which sold 

misbranded prescription drugs as well 

as some Schedule III and Schedule IV 

controlled substances in the United 

States without requiring a prescription. 

The drugs were manufactured overseas 

and then shipped in bulk to the United 

States to domestic redistributors. The 

packages did not declare their illicit 

contents and instead took steps to 

conceal their true nature. Once the 

packages entered the United States, the 

redistributors sent the bulk orders to 

second tier U.S. based distributors who 

then finally shipped the drugs to the 

customers, making the purchasers think 

their drugs came from the United States 

and not from overseas. Part of Mr. 

Funaro’s role in the scheme was to route 

some of the customer payments for the 

misbranded drugs made through 

www.ExpressPCT.com through a series 

of accounts in an effort to conceal the 

source of the funds. Mr. Funaro also 

converted proceeds into cryptocurrency 

which he used, in part, to pay 

redistributors of the misbranded drugs. 

Mr. Funaro also sent some of the funds 

to various pharmaceutical companies in 

India in order to purchase additional 

drugs and thus continue the scheme. 

As a result of this conviction, FDA 

sent Mr. Funaro, by certified mail, on 

September 6, 2023, a notice proposing 

to debar him for a 5-year period from 

importing or offering for import any 

drug into the United States. The 

proposal was based on a finding under 

section 306(b)(3)(C) of the FD&C Act 

that Mr. Funaro’s felony conviction 

under Federal law for conspiracy to 

launder money in violation of 18 U.S.C. 

1956(h), 1956(a)(1)(A)(i), and 

1956(a)(1)(B)(i), was for conduct relating 

to the importation into the United States 

of any drug or controlled substance 

because he was involved in a scheme to 

illegally import and introduce 

misbranded prescription drugs into the 

United States. In proposing a debarment 

period, FDA weighed the considerations 

set forth in section 306(c)(3) of the 

FD&C Act that it considered applicable 

to Mr. Funaro’s offense and concluded 

that the offense warranted the 

imposition of a 5-year period of 

debarment. 

The proposal informed Mr. Funaro of 

the proposed debarment and offered 

him an opportunity to request a hearing, 

providing him 30 days from the date of 

receipt of the letter in which to file the 

request, and advised him that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Mr. 

Funaro received the proposal and notice 

of opportunity for a hearing on 

September 11, 2023. Mr. Funaro failed 

to request a hearing within the 

timeframe prescribed by regulation and 

has, therefore, waived his opportunity 

for a hearing and waived any 

contentions concerning his debarment. 

(21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(b)(3)(C) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Mr. James 

Funaro has been convicted of a felony 

under Federal law for conduct relating 

to the importation into the United States 

of any drug or controlled substance. 

FDA finds that the offense should be 

accorded a debarment period of 5 years 

as provided by section 306(c)(2)(A)(iii) 

of the FD&C Act. 

As a result of the foregoing finding, 

Mr. Funaro is debarred for a period of 

5 years from importing or offering for 

import any drug into the United States, 

effective (see DATES). Pursuant to section 

301(cc) of the FD&C Act (21 U.S.C. 

331(cc)), the importing or offering for 

import into the United States of any 

drug by, with the assistance of, or at the 

direction of Mr. Funaro is a prohibited 

act. 

Dated: December 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27854 Filed 12–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2080] 

Jeremy Walenty: Final Debarment 

Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

Jeremy Walenty for a period of 5 years 

from importing or offering for import 

any drug into the United States. FDA 

bases this order on a finding that Mr. 

Walenty was convicted of one felony 

count under Federal law for conspiracy 

to smuggle goods into the United States. 

The factual basis supporting Mr. 

Walenty’s conviction, as described 

below, is conduct relating to the 

importation into the United States of a 

drug or controlled substance. Mr. 

Walenty was given notice of the 

proposed debarment and was given an 

opportunity to request a hearing to show 

why he should not be debarred. As of 

October 15, 2023 (30 days after receipt 

of the notice), Mr. Walenty had not 

responded. Mr. Walenty’s failure to 

respond and request a hearing 

constitutes a waiver of his right to a 

hearing concerning this matter. 

DATES: This order is effective December 

19, 2023. 

ADDRESSES: Any application by Mr. 

Walenty for termination of debarment 


lotter on DSK11XQN23PROD with NOTICES1